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About CIBINQOEfficacyEfficacyOverviewEfficacy of CIBINQO + Medicated TopicalsEfficacy of CIBINQO Without Medicated TopicalsReduction in Risk of FlaresLong-term Efficacy ResultsBefore and After PhotosGlossarySafetySafetySafety ProfileSafety ConsiderationsLab AbnormalitiesDosing & MonitoringDosing &
MonitoringDosingLab Monitoring

Click here for CIBINQO Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
Reduction in Risk of Flares

JADE REGIMEN was a responder-enriched, randomised, double-blind, placebo-controlled phase 3 trial to evaluate efficacy and safety of CIBINQO in 1,233 patients with moderate-to-severe AD who received CIBINQO 200 mg monotherapy in an initial 12-week open-label induction period and the responders* (n=798) were randomised to CIBINQO 200 mg, CIBINQO 100 mg, or placebo during a 40-week maintenance period to evaluate loss of response or protocol-defined flare† requiring rescue treatment.1

Continuing Dose
200 mg OL → 200 mg Double-Blinded

Reducing Dose
200 mg OL → 100 mg Double-Blinded

See full trial design >

CIBINQO has been shown to significantly reduce the risk of flares† with either dose

In patients who responded* to 12-week treatment with CIBINQO 200 mg open label

Whether patients were continued on CIBINQO 200 mg or dose was reduced to CIBINQO 100 mg, both treatment arms showed a significantly lower risk of flare† vs placebo (treatment withdrawn) through week 521,2‡

†Protocol-defined flare requiring rescue treatment: A loss of at least 50% of the EASI response achieved at week 12 (in the open-label induction period) plus a new IGA score of 2 or higher. 

Data limitations
Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus an IGA score of ≥2).

Responder criteria at week 12 were defined as achieving an IGA 0/1 with a reduction from baseline of ≥2 points and reaching EASI-75.JADE REGIMEN included a 12-week open-label induction period with CIBINQO 200 mg monotherapy, followed by a 40-week randomised maintenance period with CIBINQO 200 mg (continuing dose), CIBINQO 100 mg (reducing dose), or placebo (treatment withdrawn).AD=atopic dermatitis; OL=open label; QD=once a day; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment.CIBINQO 200 mg + TCS was shown to quickly recapture efficacy when used as rescue therapy1,3§

IIProtocol-defined flare requiring rescue treatment: A loss of at least 50% of the EASI response achieved at week 12 (open-label induction period) plus a new IGA score of 2 or higher.

Data limitations
During the rescue period, there was no control arm and all patients received CIBINQO 200 mg + TCS open label (patients knew they received active treatment).

Rescue treatment was CIBINQO 200 mg QD + any potency topical corticosteroids, topical calcineurin inhibitors, or phosphodiesterase-4 inhibitor, used per investigator’s usual practice.Recapture was defined as at least 75% improvement from rescue baseline (severity of AD at the moment of protocol-defined flare) in EASI score (EASI-75). JADE REGIMEN Study Design

Primary endpoint:

  • Loss of response or protocol-defined flare requiring rescue treatment 
Key secondary endpoint:
  • Loss of IGA 0/1 response
Biases
  • The induction period was open label; all subjects knew they were taking CIBINQO 200 mg
  • Patients may exhibit greater aggregate efficacy responses in open-label treatment periods than in double-blind, placebo-controlled studies
Data limitations
  • Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus IGA score of ≥2)
  • There is no consensus on a standardised definition of flare in a clinical and research setting
Eligible subjects had the option to enter JADE EXTEND, a long-term extension study. Patients who did not meet the responder criteria at the end of the induction period, as well as eligible patients who completed the maintenance period or the rescue period, had the option to enter JADE EXTEND.1,4TCS in the rescue period of JADE REGIMEN included any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, used per investigator’s usual practice in JADE REGIMEN.1,3
EASI-75 response is defined as at least 75% improvement in EASI score from baseline.

Although this clinical trial included adolescents, please note that CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

Explore moreAbout CIBINQO About CIBINQO LoadingSee patient results with CIBINQO in the JADE clinical programBefore and After PhotosLoading

Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.

References:Blauvelt A, Silverberg JI, Lynde CW, et al. Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial. J Am Acad Dermatol. 2022;86(1):104-112.CIBINQO Summary of Product CharacteristicsData on file. Pfizer Inc.; New York, NY.ClinicalTrials.gov. Study to investigate efficacy and safety of PF-04965842 in subjects aged 12 years and over with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects. ClinicalTrials.gov identifier: NCT03627767. Updated 20 January 2021. Accessed 9 June 2021. https://www.clinicaltrials.gov/ct2/show/NCT03627767Reich K, Silverberg JI, Papp K, et al. Long-term management of moderate-to-severe atopic dermatitis with abrocitinib: a phase 3 extension study (JADE EXTEND). Presented at: Revolutionizing Atopic Dermatitis Virtual Conference; 13 June 2021.

See full trial design >

CIBINQO has been shown to significantly reduce the risk of flares† with either dose

In patients who responded* to 12-week treatment with CIBINQO 200 mg open label

Whether patients were continued on CIBINQO 200 mg or dose was reduced to CIBINQO 100 mg, both treatment arms showed a significantly lower risk of flare† vs placebo (treatment withdrawn) through week 521,2‡

JADE REGIMEN showed that most patients who initially responded to CIBINQO 200 mg OL maintained adequate response with reduced dosing.

†Protocol-defined flare requiring rescue treatment: A loss of at least 50% of the EASI response achieved at week 12 (open-label induction period) plus a new IGA score of 2 or higher. 

Data limitations
Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus an IGA score of ≥2).

Responder criteria at week 12 were defined as achieving an IGA 0/1 with a reduction from baseline of ≥2 points and reaching EASI-75.JADE REGIMEN included a 12-week open-label induction period with CIBINQO 200 mg monotherapy, followed by a 40-week randomised maintenance period with CIBINQO 200 mg (continuing dose), CIBINQO 100 mg (reducing dose), or placebo (treatment withdrawn). AD=atopic dermatitis; QD=once a day; OL=open label; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment. CIBINQO 200 mg + TCS was shown to quickly recapture efficacy when used as rescue therapy1,3§IIProtocol-defined flare requiring rescue treatment: A loss of at least 50% of the EASI response achieved at week 12 (open-label induction period) plus a new IGA score of 2 or higher.

Data limitations
During the rescue period, there was no control arm and all patients received CIBINQO 200 mg + TCS open label (patients knew they received active treatment).

Rescue treatment was CIBINQO 200 mg QD + any potency topical corticosteroids, topical calcineurin inhibitors, or phosphodiesterase-4 inhibitor, used per investigator’s usual practice.
Recapture was defined as at least 75% improvement from rescue baseline (severity of AD at the moment of protocol-defined flare) in EASI score (EASI-75). JADE REGIMEN Study Design

Primary endpoint:

  • Loss of response or protocol-defined flare requiring rescue treatment 
Key secondary endpoint:
  • Loss of IGA 0/1 response
Biases
  • The induction period was open label; all subjects knew they were taking CIBINQO 200 mg
  • Patients may exhibit greater aggregate efficacy responses in open-label treatment periods than in double-blind, placebo-controlled studies
Data limitations
  • Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus IGA score of ≥2)
  • There is no consensus on a standardised definition of flare in a clinical and research setting
Eligible subjects had the option to enter JADE EXTEND, a long-term extension study. Patients who did not meet the responder criteria at the end of the induction period, as well as eligible patients who completed the maintenance period or the rescue period, had the option to enter JADE EXTEND.1,4TCS in the rescue period of JADE REGIMEN included any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, used per investigator’s usual practice in JADE REGIMEN.1,3
EASI-75 response is defined as at least 75% improvement in EASI score from baseline.Explore moreAbout CIBINQO About CIBINQO Loading See Patient Results with CIBINQO in the JADE Clinical Program  Before and After Photos Loading

Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.

References:Blauvelt A, Silverberg JI, Lynde CW, et al. Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial. J Am Acad Dermatol. 2022;86(1):104-112.CIBINQO Summary of Product CharacteristicsData on file. Pfizer Inc.; New York, NY.ClinicalTrials.gov. Study to investigate efficacy and safety of PF-04965842 in subjects aged 12 years and over with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects. ClinicalTrials.gov identifier: NCT03627767. Updated 20 January 2021. Accessed 9 June 2021. https://www.clinicaltrials.gov/ct2/show/NCT03627767
Efficacy
Take On Moderate-to-Severe AD With CIBINQO

Discover the efficacy of CIBINQO

 See Efficacy OverviewLoading

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Legal Category: S1A
Further information is available upon request

PP-CIB-IRL-0087 June 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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